Trial Information

Phase 1 Study of JNJ-212082 (Abiraterone Acetate) in Patients With Castration-Resistant Prostate Cancer

This study is a multicenter (more than one site), open-label (both physician and patient
know the name of the study drug), dose-escalation study in chemotherapy-naive patients with
castration- resistant prostate cancer (CRPC) to evaluate the pharmacodynamics (the study of
the action or effects of drugs on living organisms), safety, pharmacokinetics (how drugs are
absorbed in the body, how they are distributed within the body and how they are removed from
the body over time) and preliminary effectiveness of JNJ-212082. The dose of the study will
be escalated from 250 mg (cohort 1), 500 mg (cohort 2), to 1000 mg (cohort 3). Six to
twelve patients within each 250 mg, 500 mg or 1000 mg cohort will be orally administered
drug once per day. Comprising 28 days for each 1 cycle, the administration will be continued
up to discontinuation for any reasons such as progression of the disease or up to the
transition to extension study (Protocol number: JNJ-212082-JPN-203) which will be separately
planned. In addition, 5 mg of prednisolone will be orally administered twice per day since
Day 8. On receiving notification of the confirmation of safety of 500 mg of the drug,
patients of cohort 1 who are currently on continuous administration can receive increment
500 mg per day starting from the next cycle (If the dose escalation would not be appropriate
due to safety reasons, the patients will continue the original dose). Furthermore, on
receiving notification of the confirmation of safety of 1000 mg, patients of previous
cohorts who are currently on continuous administration can receive increment 1000 mg per day
as well from the next cycles (If the dose escalation would not be appropriate due to safety
reasons, the patients will continue the original dose). JNJ-212082 will be orally
administered once per day. Comprising 28 days for each 1 cycle, the administration will be
continued up to discontinuation for any reasons such as progression of the disease or up to
the transition to extension study. The drug will be administered at least 1 hour prior to
meal or 2 hours after meal. The daily dose of the drug is defined as 250 mg, 500 mg or 1000
mg. In addition, 5 mg of prednisolone (marketed) will be orally administered twice per day
since Day 8.